DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of Application No. 17/409181 (filed on 8/23/2021), which is a divisional of Application No. 16/054952 (filed on 8/03/2018), which is a divisional of Application No. 14/791107 (filed on 7/02/2015), which in turn is a divisional of Application No. 12/303872 (filed on 3/01/2010). The latter application is a national stage entry of PCT/NZ2007/000146 (filed on 6/08/2007), which claims foreign priority under 35 U.S.C. 119(a)-(d) based on application AU2006903111 filed in Australia on 6/08/2006.
Certified copy of the foreign priority document was submitted in the parent application 14/791107.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 7/26/2024 is in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in the IDS have been fully considered.
However, the listing of references in the specification (pages 36-38) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." So unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because of improper labels: Figure 10 shows two photos that are labeled as “A” and “B”. 37 C.F.R. 1.84 section (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG."”. See MPEP 608.02(V). Thus, the two photos should be labeled as “FIG. 10A” and “FIG. 10B”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
The abstract of the disclosure is objected to because there should be no space between the first four numbers and the last number in “DSM 1823 8” (line 2). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claimed method uses a novel biological material, specifically the “MH96” strain of Yersinia entomophaga. Since said biological material is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material. Applicant must meet all the requirements of 37 C.F.R. 1.801-1.809, including providing an indication of the viability of the sample when the deposit was made.
According to the specification, applicant deposited the recited biological material at DSMZ on 5/04/2006 under the accession number “DSM 18238” (Abstract; par. [0013]). If the deposit was made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by the attorney of record over his/her signature and registration number, stating that the biological material will be released to the public irrevocably and without restriction or condition upon the issuance of a patent would satisfy the requirement. Further applicant must state that the deposit will be maintained for a period of 30 years, or five (5) years after the most recent request date, whichever is longer.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention.
The claims require applying a composition that comprises, and/or a cellular extract of, a biological deposit but does not recite its corresponding accession number. The identity of the biological deposit cannot be clearly verified, thereby making the claimed invention vague and indefinite.
To overcome this rejection, independent claims 1 and 11 should be amended to recite the depository and accession number immediately after the first recitation of “Yersinia entomophaga MH96”. It is also recommended that the words “of Yersinia entomophaga MH96” after “a cellular extract” be replaced with “thereof”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,039,286 in view of Kloepper et al. (Pub. No. WO 87/00194) and Burges et al. (Formulation of Microbial Biopesticides: Beneficial microorganisms, nematodes and seed treatments; H.D. Burges, Ed.; Kluwer Academic Publishers: Dordrecht, 1988, pages 33-127; IDS-cited).
U.S. patent 10,039,286 is drawn to a method of treating a plant or a seed for an insect pest infestation by applying to the plant or seed a biopesticide composition comprising a biopesticide effective amount of isolated live Yersinia entomophaga MH96 (accession no. DSM 18238) obtained from a culture of said strain, a cellular extract thereof, and/or whole broth culture thereof.
The U.S. patent’s method differs from that claimed invention in that it does not include applying the composition and/or cellular extract thereof to a soil. It also does not specify the form of the composition, nor having an insect attractant.
Regardless, soil application of compositions containing beneficial bacteria and the recited formulations are known and conventional in the art as substantiated by Kloepper et al.. Kloepper et al. teaches treating the soil environment in which plants are grown with a liquid, solid, or semi-solid composition comprising emergence-promoting rhizobacteria (first par., page 6), aside from treating seeds or plants (first par., page 8). The composition is provided as a suspension in an aqueous or non-aqueous medium, wettable powder, granule, or any other known formulations (first par., page 8). Kloepper et al.’s teachings are supported by Burges et al., which discloses formulations of microbes like bacteria for controlling insects including dry formulations like granules and liquid formulations like water-based or oil-based suspensions (left col., page 43; right col., page 49; left col., page 51). Burges et al. also teaches providing the dry formulations as slow-release products (left and right col., pages 91-93). Furthermore, Burges et al. teaches incorporating phagostimulants to attract an insect to a particular area and encourage it to eat more once it is there (left col., page 62; Table 3.14, pages 63-64). Accordingly, a person with ordinary skill in the art would have provided the disclosed composition in any of said formulations and/or apply it on soil with reasonable expectation that Y. entomophaga MH96 would be successfully delivered and protect the plant from insects. Given that the U.S. patent’s method utilizes a composition defined as a biopesticide composition, it would have also been obvious to add a phagostimulant as its presence would facilitate protection of the plant by attracting insects and exposing them to the biopesticide composition. Combining prior art elements according to known methods yields nothing more than predictable results.
The claims of the instant application are therefore obvious over U.S. patent 10,039,286 in view of Kloepper et al. and Burges et al..
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,054,704 in view of Kloepper et al. (Pub. No. WO 87/00194) and Burges et al. (Formulation of Microbial Biopesticides: Beneficial microorganisms, nematodes and seed treatments; H.D. Burges, Ed.; Kluwer Academic Publishers: Dordrecht, 1988, pages 33-127; IDS-cited).
The U.S. patent is drawn to a method comprising applying a biopesticide composition comprising an effective amount of Yersinia entomophaga MH96 (accession no. DSM 18238), a supernatant from a whole broth culture thereof, a cellular extract thereof, or a sonicated cell filtrate thereof, to a surface. The amount applied is sufficient to act as a biopesticide against at least one invertebrate selected from Table 14. In some embodiments, the biopesticide composition is formed into a prill or granule.
Although the claims at issue are not identical (does not specify the surface to be a plant or soil), they are not patentably distinct from each other because the disclosed composition is specified to act as a biopesticide and it is known and routine in the art to apply such composition to a plant and/or the soil in which the plant is intended to be grown. Moreover, the various recited formulations and inclusion of phagostimulants are conventional in the field. Kloepper et al., for example, teaches treating a plant or the soil in which the plant is grown with a composition comprising emergence-promoting rhizobacteria, wherein the composition can be a suspension in an aqueous or non-aqueous medium, wettable powder, granule, among others. And as discussed above, Burges et al. also teaches that these different types of formulations including slow-release dry formulations, as well as additives like phagostimulants, are suitable for compositions intended to control insect infestation. Based on the teachings of Kloepper et al. and Burges et al., one with ordinary skill in the art would have prepared the U.S. patent’s composition as one the recited forms, add a phagostimulant, and/or apply it on soil in which a plant is going to be cultivated. Obviousness is based on the rationale that combining prior art elements according to known methods yields predictable results.
Hence, the instant claims are deemed obvious over U.S. patent 10,039,286 in view of Kloepper et al. and Burges et al..
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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